510(k) · Cleared
ClearedMicrolife Instant Digital Electronic Thermometer, Model QT1JC1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Intellectual Property GmbH · FLL Continuous Measurement Thermometer
Cleared on Dec 6, 2006 as substantially equivalent to K031958 (Microlife Intellectual Property GmbH, 2003) after a 72-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Dec 6, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943695 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK943695 SuretempAdvanced Bioresearch Assoc. · 1995
- 3 generations backK990168 Microlife IT2CA1Microlife Systems AG · 1999
- 2 generations backK012136 Avita Agil IT 101 Instant Digital ThermometerAvita Corporation · 2001
- 1 generation backK031958 Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003
- This deviceK062867 Microlife Instant Digital Electronic Thermometer, Model QT1JC1Microlife Intellectual Property GmbH · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943695 | Suretemp | Advanced Bioresearch Assoc. | 1995 | — |
| −3 | K990168 | Microlife IT2CA1 | Microlife Systems AG | 1999 | — |
| −2 | K012136 | Avita Agil IT 101 Instant Digital Thermometer | Avita Corporation | 2001 | — |
| −1 | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1 | Microlife Intellectual Property GmbH | 2003 | — |
| 0 (this device) | K062867 | Microlife Instant Digital Electronic Thermometer, Model QT1JC1 | Microlife Intellectual Property GmbH | 2006 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1Summary page 2…omparison to Predicate Devices: The Microlife Instant Thermometer, Model QT1JC1 is substantially equivalent to Microlife instant Thermometer, Model QT1 JAl, K#031958 which have the same intended use and are similar in design to the predicate device. The Microlife Instant Thermometer… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K031958.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Microlife QT1JC1 instant Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm.
The Microlife QT1JC1 Instant Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 5-seconds in oral and rectal mode, 8-seconds in under the arm mode-predicative temperature ), or standard mode ( actual determination of temperature).
The device is for the adult and pediatric population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062867: Microlife Instant Digital Electronic Thermometer, Model QT1JC1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026